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False Claim Act Essay

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OFF-LABEL PROMOTION UNDER FALSE CLAIM ACT Pharmaceutical industry plays a vital role in public health. These companies develop, manufacture and market medicines. Considering public health safety, government laid down laws and their agencies established regulations to market these medicines. Companies need to justify through clinical trials that their products are beneficial to consumers. To release a product in United States, they have to file a New Drug Application (NDA) with Food and Drug Administration (FDA) and should gain approval of the product. While filing an NDA, they must notify them for which specific purposes and in which manner (route of administration, dose, frequency etc.) the drug will be marketed. The manufacturers …show more content…

Congress felt the need for such Act due to the rampant fraudulent claims during the Civil War. Lincoln law provided Qui Tam actions which means “who brings action for the King as well as himself.” These provisions state that anyone who is submitting false claims to the government is liable to pay double the government charges and $2000 as penalty for each claim. Those whoever files a lawsuit, called as “relator” will get half of the amount from government recovered money. But, this Act was not successful in fighting against fraud under all conditions or circumstances. Hence, The Federal False Claims Act was not effective for the most period from late 1800’s and was not changed until …show more content…

The District Court applied three-prong Central Hudson Test to decide whether if policies constraints on commercial speech overreached constitutional limits. The Court ruled in favour of WLF inferring that guidance documents satisfied first and second parts of Central-Hudson but did not satisfy third part of it. FDAMA was also passed at the same time which clearly stated that dissemination of information by manufacturers for off-label use was prohibited. But the same rule applied to FDAMA off-label provisions which made them

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